SOW-OC-2026-134410- Final- SAM.pdf

STATEMENT OF NEED

Bench Top Single Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP-MS) System for Color Certification Program

Description of Purpose

This request is for the Division of Color Certification and Technology (DCCT), within the Office of Cosmetics and Colors, to acquire a new inductively coupled plasma mass spectrometer (ICP- MS). This system will replace an existing Agilent 7800 ICP-MS, which was purchased in May 2016 and will reach the end of its guaranteed support in October 2028. Timely replacement is necessary to ensure continuous service and to prevent any interruption in color certification activities. DCCT needs an instrument capable of determining element concentrations and accurate element ratios at low concentrations. In contrast to conventional quadrupole-based instruments, an instrument equipped with a kinetic energy discrimination-capable collision/reaction cell will provide the agency with the capability for achieving lower detection limits and higher accuracy in determining element concentrations in complex color additive and other matrices.

The instrument shall have a fully developed software package to allow the instrument to perform up to its design specifications and facilitate the transfer of existing methods. For seamless integration, the instrument software must be able to control all components of the ICP-MS system including autosampler, advanced diluting system, reaction system, plasma, mass analyzer, and torch. The software shall have comprehensive auto-tuning capabilities for plasma parameters, torch position, collision cell, lenses, mass analyzer, detector, and detector pulse/analog factors in one single step.

The proposed instrument is required to continue and expand the efforts of the FDA to protect the U.S. food supply and to respond to emergencies in a timely and accurate manner. DCCT staff will use the equipment for the following purposes:

• For analysis of color additives with regulatory limits of toxic and other elements

• For the development of new methods for quantification of low-level (parts per billion) heavy metals primary arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), manganese (Mn), and mercury (Hg) in various color additives

• For characterization of reference standard materials prepared in-house

• For the analysis of samples obtained during inspection

Background

The U.S. Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act and other applicable laws and regulations intended to protect consumers’ health and safety.

FDA’s Color Certification Program assures the safe use of certified color additives (synthetic dyes and pigments) in foods, drugs, cosmetics, and certain medical devices. Certified color additives are listed in 21 CFR Parts 74 and 82 together with specifications for their impurities.

DCCT is responsible for chemical measurements leading to certification or rejection of batches of color additives intended for use in food, drugs, cosmetics, and medical devices in the U.S.

Batch certification of color additives is a regulatory premarket enforcement function. During the certification process, analyses are performed to determine whether each batch meets the identity and specifications described by the listings in the Code of Federal Regulations (CFR) as well as FDA's current closer-to-zero initiative approach to reducing exposure to toxic elements in regulated products. The trace elements in the color additives are quantitated with ICP-MS.

Scope

The contractor shall provide a single quadrupole inductively coupled plasma mass spectrometer system with all necessary supplies and accessories required for installation and start-up. The vendor shall install the instrument and provide training sessions. A minimum period of one year product warranty shall be provided for the instrument with additional 3 option years for service schedules that will include the terms and conditions described.

Salient Characteristics

1. General

The system shall be of a compact bench-top design to fit the space constraints of the laboratory and shall have an open architecture sample introduction area with external rotary pump(s) configured to fit under or behind the laboratory bench. The footprint for both the ICP-MS and the autosampler shall be smaller than height x width x dept: 35" x 45'' x 35”.

The components and/or equipment shall be new, not used or refurbished, or previously used for demonstration.

The system shall be a turn-key solution—the contractor shall be responsible for providing all hardware, components, instruments, and software that are otherwise required to meet these salient characteristics.

The contractor shall provide the entire system including all necessary supplies and accessories and fittings required for immediate start-up and installation on-site at the designated laboratory delivery location.

Instrument software must be able to control all components of the ICP-MS system (including autosampler, advanced diluting system, reaction system, plasma, mass analyzer, chiller, pump) with a single software program/package.

The ICP-MS software shall demonstrate exceptional consistency and operational simplicity through advanced system setup and comprehensive auto-tuning of plasma operating parameters, torch alignment, collision cell conditions, ion optics (lenses), mass analyzer settings, detector parameters, and percent abundance factors — all in one single step

All solutions, standards, and/or consumables required to perform initial instrument qualification are the responsibility of the offeror.

Single hyperbolic quadrupole for mass analysis, Agilent 7850 (G8422AA) or equal.

Sample Introduction system, Agilent SPS4 (G8415A) or equal.

Advanced dilution system, Agilent ADS 2 (M5172A) or equal.

Operating software and shall be Microsoft Windows based software Microsoft Office modules needed for data analysis and interpretation shall be included.

Color laser printer.

Heat exchanger/chiller for cooling the interface. The cooling water supply to the ICP-MS mainframe shall be supplied by a non-refrigerated heat exchanger to reduce maintenance cost.

Roughing pump with noise reduction (quiet) cover.

Gas regulator(s).

Perfluoroalkoxy alkanes inert sample introduction kit with 2.5 mm sapphire injector PFA concentric nebulizer.

The instrument installation and user familiarization training shall be included in price.

3-day on-site application consulting, routine operation and operator maintenance training A comprehensive spares kit, including nickel sample and skimmer cones, shall be supplied. An extra set of nickel sample and skimmer cones shall also be included.

Spectrometer must be covered under warranty for a period of 1 year after installation.

The warranty shall include unlimited on-site visits for problem resolution.

The price proposal shall include optional service agreements for three additional years, covering all parts and labor for repairs or defects. This shall not obligate the FDA to purchase the service agreements. Optional service agreements shall not be exercised until expiration of the standard manufacturer's warranty.

2. Sample Introduction, Agilent SPS4 (G8415A) or equal

An integrated, computer-controlled, high-precision peristaltic pump (pump speed 0.1 to

0.5 rps) with a minimum of three channels and ten rollers shall be provided for independent pumping of the sample, internal standard, and spray chamber drain.

The quartz spray chamber shall be thermoelectrically controlled and shall be fitted with a concentric micro-mist nebulizer.

Temperature controlled spray chamber (-5 to 20 °C) Ultra-high matrix introduction capability shall be included, enabling reliable analysis of samples containing ≥5% total dissolved solids (TDS).

A high throughput autosampler is required with a minimum capacity of at least 42 50-mL and 120-15 mL sample vials as well as positions for tune and rinse bottles.

The autosampler shall come with a cover to prevent dust from entering sample containers during analysis.

Autosampler capable of automated monitoring of signal washout using computer software.

User selectable intelligent-automated monitoring of washout to the baseline and pre-emptive rinse routines for increased productivity.

It shall have pumped drain kit.

The sample introduction system shall be automatically tuned via the integrated software.

3. Advanced dilution system, Agilent ADS 2 (M5172A) or equal

Capable of automatically preparing calibration standards from a single stock standard.

Preform fixed or predefined dilutions to cut down on manual pre-analysis dilutions, consumable usage, and laboratory waste.

Performs reactive dilution when a measured signal is over range, reducing the need for repeat analyses.

4. Gas flow controllers

Instrument shall have computer-controlled gas flow controllers that precisely regulate the flow of gas in the instrument’s plasma and interface systems (plasma, torch, nebulizer).

One collision/reaction cell gas line shall be included as standard. The system shall be upgradable to three cell gas lines in total, to cover all possible applications. It is not acceptable to use an external gas manifold for the additional cell gas lines because it increases the dead volume and changeover cannot be automated within run.

5. Vacuum and Cooling system

The instrument vacuum system shall consist of a single floor mounted external rotary pump, and single turbomolecular pump.

6. Plasma and ion optics

a. Torch

One piece quartz torch with injector diameter of 2.5 mm for fast, easy replacement and high matrix tolerance. Demountable torches that use O-ring seals or require alignment of the separate concentric tubes are not acceptable, as they increase maintenance time and possibly introduce sample contamination.

Torch position shall be fully computer controlled and fully auto tunable via the software in all three axes (horizontal and vertical position and sampling depth). The movement in each axis shall be independent of the other two. Torch position and reproducibility should be 0.1mm in all three axes. Computer readout of torch position is required for method and data audit purposes.

Solid state electronics in both plasma and quadrupole RF generators.

b. RF generator

For tolerance of changes in sample matrix, the system shall include a high power-transfer efficiency and maintenance-free solid state digital drive 27 MHz RF generator with variable-frequency impedance matching.

Minimum RF Power Range from 1000 W to 1600 W The RF generator shall be able to tolerate change from volatile organic solvents to aqueous samples without affecting plasma stability.

c. Interface

Shielded torch interface for precise ion energy control Shall come standard with nickel sampling (0.1mm) and skimmer (0.45mm) cones with option for use of platinum cones

d. Ion optics

Conical extraction and off-axis focus lens for uniform mass response curve.

The main ion-lens assembly shall be located before the gate valve to reject neutrals and matrix components before they can enter the main high vacuum chamber.

The main ion-lens assembly shall ensure that only ions enter the high vacuum region.

An ion lens that incorporates a 90° ion deflection shall be the method of protecting the detector from stray photons and high-energy neutrals which would cause a raised background. However, due to the potential for ion energy, space charge and mass bias effects caused by high angles of deflection of the primary ion beam, the 90° deflection shall occur after mass separation—i.e., the deflection shall occur between the quadrupole mass analyzer and the detector.

The main ion-lens assembly shall be located outside the main vacuum system and allow for removal, cleaning and replacement without opening the main vacuum system.

7. Collision/reaction system

To enable fast, stable and consistent interference removal, the cell shall be thermally-stabilized and operated with fixed RF amplitude for the full mass range.

The cell shall switch between gas modes and between gas and no gas mode in 3 seconds or less.

The ICP-MS shall be able to be used for semi-quantitative analysis in cell mode using helium cell gas. The cell shall operate effectively in collision mode using pure helium.

The instrument shall be able to be used for the multi-element analysis of unknown samples containing chloride (Cl), sulfate (SO4), and organic content, without the need for polyatomic interference correction equations.

8. Quadrupole mass analyzer

The system shall use a true hyperbolic quadrupole, operating at high (3 MHz) frequency with a mass range of 2 - 260 amu

The system shall have mass scan speed >3000 amu/sec and variable mass resolution <0.3 u to >1.0 u.

The system shall have mass stability of ≤0.05 u per day ≤0.1 u per six months The system shall be capable of a linear dynamic range of at least 9 orders of magnitude without the need to use increased resolution at the highest concentration point.

The detector dead time shall meet industry standard timing and be identical in both pulse and analog modes.

The sensitivity for low mass (>10), mid-range mass (59-115), and high mass range (205-

238) shall be at least 50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions.

The background at m/z 9 shall be less than 2 cps when operating under normal (no cell gas) instrumental conditions

Oxide ratios measured using CeO+/Ce+ <2% when operating under normal (no cell gas) instrumental conditions.

Double charged ratios measured using Ce2+/Ce+ <3% when operating under normal (no cell gas) instrumental conditions.

Short-term signal precision measured under normal (no cell gas) instrumental conditions shall be <3% relative standard deviation over 20 minutes.

Long-term signal precision measured under normal (no cell gas) instrumental conditions shall be <4% relative standard deviation over two hours.

The detector shall offer a minimum dwell time of 3 msec in all modes (TRA and spectrum).

The system shall include a collision/reaction cell to eliminate or significantly reduce interferences from molecular species and allow for accurate multi-element analysis of elements such as chromium, arsenic, selenium, thallium, cadmium, lead, antimony, and mercury under the same experimental conditions.

The systems shall have the option of adding a 2nd and 3rd cell gas line to cover all possible applications, both current and future.

The instrument shall be capable of eliminating interference at different masses, without the use of interference equations to correct for polyatomic interferences, in accurate determination of variable high matrix samples.

The collision/reaction cell shall be able to reduce polyatomic interferences in collision mode using pure helium, hydrogen, or oxygen.

9. Data system:

The instrument shall include software for data acquisition, processing and reporting.

The instrument shall include one-click plasma setting for simpler, more reproducible plasma optimization.

The instrument shall include the capability for remote monitoring of instrument status and run progress and support remote control of instrument and run processes using the ICP-MS vendor's software utility running on a smartphone or tablet.

The ICP-MS system shall include tutorial and standard operating procedures in electronic format for ease of operating and implementing software.

The instrument control software shall offer an automated method setup wizard to users to build a fully functional method by simply asking a few questions..

Preventative Maintenance and System Updates

One annual preventative maintenance (PM) visit shall be completed one month prior to the end of the warranty period. The contractor shall be responsible for all travel, parts, labor, and consumables required to complete these services. The PM shall include at minimum the cleaning of the equipment, replacement of consumable parts, changing of vacuum pump oil, calibration, and updates to the software and firmware. The contractor shall assign a representative to serve as a point of contact in addressing issues with any system component and provide a services report after completion of the PM.

At least one annual preventative maintenance (PM) shall be performed by the Contractor. The vendor shall provide service and application support within 24 hours and on-site repairs within 3-5 days.

The 1-year manufacturer’s warranty and 3 option years (12 month each) shall cover:

Single Quadrupole (ICP-MS): Agilent 7850 ICP-MS or equal, including: heat exchanger, autosampler, advanced diluting system, roughing pump, plasma, torch, tuning and standard solutions.

Installation

The following shall be demonstrated at the time of installation.

A. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The contractor shall demonstrate upon installation that the system is fully functional and meets salient characteristics. Any expenses, including chemicals and reagents, related to the demonstration are at the expense of the contractor.

B. The results of the sensitivity test shall meet or exceed the values supplied in the contractor quote. Additionally, the background, oxide ratios, double charged ratios, short-term signal precision, and long-term signal precision must be demonstrated after installation.

C. Performance for the helium reaction/collision mode must be demonstrated after installation.

D. The contractor shall provide certificates of analysis (COA) for all chemical standards used to verify sensitivity, as well as a standard operating procedure (SOP) describing how the tests will be performed.

E. The contractor shall transfer all methods from existing ICP-MS systems to their system and confirm that quality control and sensitivity parameters meet the FDA methods.

Packaging and Marking

1. The instrument shall be delivered with all necessary supplies and accessories required for the installation and start-up. Cost of installation and user-familiarization training should be included in the price.

2. The instrument shall be covered under warranty for one year after installation.

3. Vendor should provide insured shipping to:

Nebebech Belai, HFS-106 U.S. Food and Drug Administration, CPK2 Office of Cosmetics and Colors, Room 1059 4300 River Road College Park, MD 20740

Inspection and Acceptance

The inspection and acceptance of the instrument will be handled by any of the following individuals: Nebebech Belai.